AU2010317679B2 - Support system for bioprosthetic valves with commisural posts with heart-shaped openings - Google Patents

Support system for bioprosthetic valves with commisural posts with heart-shaped openings Download PDF

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AU2010317679B2
AU2010317679B2 AU2010317679A AU2010317679A AU2010317679B2 AU 2010317679 B2 AU2010317679 B2 AU 2010317679B2 AU 2010317679 A AU2010317679 A AU 2010317679A AU 2010317679 A AU2010317679 A AU 2010317679A AU 2010317679 B2 AU2010317679 B2 AU 2010317679B2
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support system
openings
opening
horizontal
shaped opening
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Efstathios-Andreas Agathos
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418Scaffolds therefor, e.g. support stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004Rounded shapes, e.g. with rounded corners
    • A61F2230/0013Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

A novel support system for bioprosthetic cardiac valves with heart shape commissural posts (18) and intercommissural conjunctions with long openings with oval closures (8), allows the better function of the valve by diminishing the forces applied on the leaflets during the cardiac cycle.

Description

WO 2011/058385 PCT/GR2010/000050 SUPPORT SYSTEM FOR BIOPROSTHETIC VALVES WITH COMMISURAL POSTS WITH HEART-SHAPED OPENINGS FIELD OF INVENTION The present invention relates to the field of surgical implants, and in particular to 5 support systems or stents for bioprosthetic cardiac valves. BACKGROUND The human heart is a concave muscular organ, consisted of two atria and two ventricles, right and left. The atria communicate with the ventricles with the 10 atrioventricular valves. The left atrium communicates with the left ventricle through the mitral valve and the right atrium communicates with the right ventricle through the tricuspid valve. At the output of the left ventricle, there is the aortic valve and at the output of the right ventricle there is the pulmonary valve. The function of the valve is to allow the one way flow through them. The valves consist of leaflets, three in number, 15 apart the mitral valve where consists of two leaflets. The leaflets open to allow the blood to pass through them and close to prevent the regurgitation. There are conditions that this mechanism fails with the result of non-physiological flow through them. In some congenital or acquired diseases, there is a hardening of the leaflets, more commonly due either to calcification or to rheumatic fever, which results to 20 difficulty of fully opening of the leaflets and passing the blood through them. In these circumstances, the patient presents with the symptoms of valve stenosis. In some circumstances, the leaflets do not come in conduct when they close, which results to blood leakage and the patient presents with the symptoms of valve regurgitation. In severe circumstances of stenosis or regurgitation, the diseased valve 25 has to be replaced with a new prosthetic valve. There are mainly two types of prosthetic valves for replacement: the mechanical and the biological. The mechanical valves has movable parts, mainly from graphite, while the biological valves are derived either from porcine aortic valve, or bovine pericardium (E. Andreas Agathos, Albert Starr: "Aortic Valve Replacement", Curr Prob Surg, July 30 1993: Vol XXX, No 357, pp 610-637), or from the aortic, pulmonary and the pericardium derived from seals (E. Andreas Agathos, "Human Cardiac Valve Placement with Marine Mammal Ventricular Outflow (Aortic or Pulmonary) Valves, U.S. patent No 6,165,216, issued Dec. 26, 2000, and E. Andreas Agathos, "Human Cardiac Valve Replacement with Seal's Cardiac Valve (Aortic or Pulmonary), Greek patent No 1005718, issued on July 1 1, 2007. 5 The bioprosthetic valves show an advantage over the mechanical valves, as they do not need the daily intake of anticoagulants, thus producing less incidence of thromboembolic episodes, hemorrhage and infectious endocarditis. The main disadvantage though is that they do not last as long as the mechanical valves do. The bioprosthetic valves need a support system (stent) made of biomaterial, onto with D the animal tissue is placed. There are many methods of placing animal tissue on a support system such as "Method of Leaflet Attachment for Prosthetic Heart Valves", U.S. patent No. 4,501,030, issued Feb. 26, 1985, "Tissue Heart Valves and Stent", U.S. Pat. Nos. 5,163,955, 5,423,887 and 5,489,298 to Love et al and "Prosthetic Heart Valve with Slit Stent", U.S. patent No. 6,936,067, issued on Aug. 30, 2005 to Buchanan; Eric S. 5 Any discussion of the prior art throughout the specification should in no way be considered as an admission that such prior art is widely known or forms part of common general knowledge in the field. SUMMARY OF THE INVENTION According to a first aspect, the present invention provides a support system for ?0 bioprosthetic cardiac valves constructed of a material comprising an inflow opening defined by an inferior surface of the support system, an outflow opening defined by a superior surface of the support system, three commissural posts, each post having a single heart shaped opening, and intercommissural conjunctions with two horizontal openings with oval closures positioned at a level above said inferior surface, wherein each single heart shaped opening is of a size such 5 that it extends from below said superior surface toward said inferior surface to a level equal to or greater than said horizontal openings, and wherein each single horizontal opening has substantially parallel sides, such that the intercommissural conjunctions have less open area than closed area. According to a second aspect, the present invention provides a prosthetic valve, 0 comprising the support system of the first aspect and flexible leaflets. 2 According to a third aspect, the present invention provides a support system for bioprosthetic cardiac valves comprising an inflow opening defined by an inferior surface of the support system, an outflow opening defined by a superior surface of the support system, three commissural posts, each post having a single tear drop shaped opening, and intercommissural 5 conjunctions with horizontal openings with oval closures positioned at a level above said inferior surface, wherein each single tear drop shaped opening is of a size such that it extends from below said superior surface toward said inferior surface to a level equal to said horizontal openings, and wherein each single horizontal opening has substantially parallel sides, wherein there is less open area in the intercommissural conjunctions than closed area. ) Unless the context clearly requires otherwise, throughout the description and the claims, the words "comprise", "comprising", and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in the sense of "including, but not limited to". The present invention relates to the field of surgical implants, and in particular to 5 support systems or stents for bioprosthetic cardiac valves. In one embodiment, the present invention contemplates a support system for bioprosthetic cardiac valves comprising an inflow opening defined by an inferior surface of the support system, an outflow opening defined by a superior surface of the support system, three commissural posts, each post having a single heart shaped (e.g. approximately triangular) opening, and intercommissural conjunctions with ) horizontal openings with oval closures positioned at a level above said inferior surface, wherein each single heart shaped opening is of a size such that it extends from below said superior surface toward said inferior surface to a level equal to or greater (i.e. lower) than said horizontal openings, and wherein each single horizontal opening has substantially parallel sides. In another embodiment, the present invention contemplates a support system for 5 bioprosthetic cardiac valves comprising an inflow opening defined by an inferior surface of the support system, an outflow opening defined by a superior surface of the support system, three commissural posts, each post having a single tear drop shaped (e.g. 2a WO 2011/058385 PCT/GR2010/000050 approximately triangular) opening, and intercommissural conjunctions with (two or four) horizontal openings with oval closures positioned at a level above said inferior surface, wherein each single tear drop shaped opening is of a size such that it extends from below said superior surface toward said inferior surface to a level less than or equal to (i.e. but 5 not lower) than said horizontal openings, and wherein each single horizontal opening has substantially parallel sides. It is preferred that there is less open area (created by the openings) in the intercommissural conjunctions than closed area (being the structure itself). Having large holes or openings in the conjunctions renders the whole support system (or stent) fragile 10 and causes it to fail and break at the conjunctions. BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 A panoramic view of one embodiment of a new bioprosthetic support system of the present invention with single heart shaped (or approximately triangular) openings in 15 three commissural posts and three intercommissural conjunctions, each intercommissural conjunction having two horizontal openings, each horizontal opening having parallel or substantially parallel side, such that the intercommissural conjunctions have less open area than closed area. Fig. 2 A side view of one embodiment of a new support system of the present invention 20 from outside inwards showing three heart shaped (or approximately triangular) openings each of a size such that it extends from below the superior surface toward the inferior surface to a level equal to or greater (i.e. lower) than said horizontal openings. Fig. 3 An isolated view of one embodiment of a single heart shaped commissural post which is part of the support system of the present invention. 25 Fig. 4 A side view of another embodiment of the support system of the present invention showing three commissural posts with single tear drop (or approximately triangular) shaped openings surrounded by a plurality of small holes for stitching, wherein the size of the small holes for stitching are less than 1/20h (and preferably less than 1/40"' and more preferably less than 1
/
6 0 th) the size of the single tear drop shaped opening, and wherein 30 each tear drop shaped opening is of a size such that it extends from below the superior surface toward the inferior surface to a level less than or equal to (i.e. but not lower than) 3 WO 2011/058385 PCT/GR2010/000050 the level of said horizontal openings. Fig. 5 A side view of one embodiment of the support system showing a single commissural post with a single tear drop shaped opening defined by an isosceles triangle (wherein the two equal angles, e.g. of 65 degrees, are at the bottom of the tear drop 5 opening, and the top angle is e.g. 50 degrees). Fig. 6. A side view of a prior art support system (described in U.S. Patent 4,626,255) showing three commissural posts, each with two large circular openings (in contrast to the single opening of the embodiments of the present invention described above), and three conjunctions with horizontal openings separated by single large circular opening. 10 Fig. 7. A side view of a prior art support system (described in U.S. Publication No. 2008/0147179) showing three commissural posts, each with a single large bottle shaped opening, and intercommissural conjunctions with two large openings having non-parallel sides such that the intercommissural conjunctions have more open area than closed area. Such large openings in the conjunctions renders the support system fragile such that it 15 will likely break at the conjunctions. REFERENCE NUMERALS 2 commissural posts 4 outflow orifice of the support system 20 6 heart shaped or tear drop shaped openings in the commissural posts 8 long horizontal openings with oval closures at the intercommissural conjunctions 10 outside surface of the support system 12 concave surface of the superior part of the commissural post 14 elevated edge of the commissural post 25 16 inflow orifice of the support system 18 support system for bioprosthetic cardiac valves 20 superior surface of the support system 22 inferior surface of the support system 24 intercommissural conjunction 30 25 small holes for stitching 26 single top hole for stitching 4 WO 2011/058385 PCT/GR2010/000050 DEFINITIONS As used herein, the term "heart shaped" or "tear drop shaped" can be viewed as approximately the shape of a triangle (see Figure 5). In can be viewed as being formed by the intersection of five circles. For example, one can define the geometry that is 5 produced when an arc of a circle with a radius of 3mm, intersects at the top with two arcs of circles with a radius of 15m each, while two other arcs of circles with radius of 2mm each, intersect the aforementioned arcs of 15mm radius, bilaterally and downwards. Thus an internal triangle is produced when the centers of each smaller arc are connected together. The top angle of the produced triangle can be 50 degrees and the other two 65 10 degrees each. DESCRIPTION OF THE INVENTION AND EMBODIMENTS An illustrative embodiment of the present invention is shown in Fig 1 which provides a panoramic view of the new support system of bioprosthetic cardiac valves 18 15 according to this novel invention. The outflow orifice 4 is shown, along with three commissural posts 2 with heart shaped openings 6 and the elevated edges 14 at the commissural posts 2. The elevated edges 14 of the commissural posts follow the normal geometry of the human cardiac valve, facilitating so the surgical implantation of the bioprosthetic valve. The commissural posts 2 have a heart shape appearance, allowing so 20 the slight outwards movement of the placed biological tissue or from any origin made leaflets, so eliminating the catastrophic forces applied on the commissural posts and subsequently the leaflets. The commissural posts 2 are connected to each other with the intercommissural conjunctions 24. Between the outside surface of the support system 10 and the outflow orifice of the support system 4 and along the length of the 25 intercommissural conjunctions 24 there are two long horizontal openings with oval closures 8, to facilitate the placement of support stitches through them. The size of these horizontal openings is such that there is less open area in the conjunctions 24 than closed area, in order to improve the strength of the support system. Fig. 2 is a view of one embodiment of the new bioprosthetic valve support system 30 18 from outside inwards. The concave surface of the superior part of the commissural post 12 allows the placement of biological tissue or from any origin made leaflets, in such 5 WO 2011/058385 PCT/GR2010/000050 a way as to diminish even more the catastrophic forces applied on them and the heart shaped openings 6 of the commissural posts 2 during the cardiac cycle. Along the intercommissural conjunctions 24 there are two long horizontal openings with oval closures 8, with such dimensions as to facilitate the placement of biological tissue or from 5 any origin derived leaflets from the superior surface 20 and the inferior surface 22 of the support system. Fig. 3 shows a view of one embodiment of the heart shaped opening in the commissural post 6. The elevated edge 14 of the commissural post follow the geometry of a human valve. The heart shape commissural post 2, allows the slight outward 10 movement of the placed biological tissue or from any origin made leaflets, so to diminish the friction forces applied on them during systole, facilitating so the opening of the valve. In the same matter the inward movement during diastole, facilitates the closure of the valve. Fig. 4 is a side view of another embodiment of the support system 18 of the 15 present invention showing three commissural posts 2, each with a single tear drop (or approximately triangular) shaped openings 6 surrounded by a plurality of small holes for stitching 25, wherein each tear drop shaped opening 6 is of a size such that it extends from below the superior surface 20 toward the inferior surface 22 to a level preferably less than (or equal to but not lower than) the level of said horizontal openings 8. Note 20 that the size of these horizontal openings 8 is such that there is less open area in the conjunctions 24 than closed area, in order to improve the strength of the support system. The advantage of the smaller holes for stitching 25 is to facilitate the stitching of the tissue through them. Having more holes and of smaller size, it gives a better anchorage to the stitched tissue. Also it provides better stability of the stent as an entity. While not 25 limited to particular sizes, the dimensions of these holes for stitching 25 are preferably 0.35mm in diameter, with the exemption of a larger hole for stitching 26 at the top of each post 2 which is preferably 0.50mm in diameter. Fig. 5 is a side view of a portion of one embodiment of the larger support system (not shown) showing a single commissural post 2 with a single tear drop shaped opening 30 6 defined by an isosceles triangle (wherein the two equal angles, e.g. 65 degrees, are at the bottom of the tear drop opening), and wherein each tear drop shaped opening 6 is of a 6 WO 2011/058385 PCT/GR2010/000050 size such that it extends from below the superior surface 20 toward the inferior surface 22 to a level less than or equal to (i.e. but not lower than) the level of said horizontal openings 8. The present invention consist a novel bioprosthetic cardiac valve support system 5 with heart shape commissural posts. The function of this novel invention is to support the leaflets derived from tissue such as the aortic or pulmonary valve of the seal, the porcine aortic valve, leaflets made from pericardium of seal, bovine, equine, porcine or any other suitable tissue. At the same way the present invention may support leaflets made from any biocompatible material. The heart shape commissural post gives an extra opening at 10 the valve, allowing the outwards or inwards movement of this part of the valve, reducing significantly the applied catastrophic forces, during systole or diastole of the cardiac cycle. The outward movement of the heart shape commissural post, during systole, facilitates the opening of the leaflets, while the inward movement of the commissural posts, during diastole, facilitates the better closure and avoidance of backflow of the 15 blood. It is not intended that the present invention be limited to particular dimensions. However, it is preferred that the "heart shaped" stent is produced in diameters from 15mm up to 33mm, as this is to resemble all the different sizes of human cardiac valves. The dimensions of this geometrical design, defined as "heart shape", can be modified 20 from the given example, as for keeping the defined geometry to fit at the different sizes of the stent. The number of the horizontal openings at the conjunctions, while shown to be two in the drawings, can be four for the larger sizes of the stent. More specifically, for the stents sized 29mm up to 33mm, four horizontal openings are preferred so to facilitate the anchorage and stitching of the tissue and the dacron fabric. 25 The material of this new support system for bioprosthetic cardiac valves with heart shape commissural posts can be made from any biocompatible material, which is material compatible with blood and human tissue. Common medical materials can be used, such as those easily found in tie market. These materials will be able to be sterilized with exposure to steam, gamma-radiation, chemical sterilization, such as 30 glutaraldehyde, formaldehyde, ethylene oxide and propylene. The present invention can be made from hard or semi hard material, such as polymer, metal, ceramic, pyrolytic 7 WO 2011/058385 PCT/GR2010/000050 carbon and combination of the above. Proper polymers are the polyacetals, such as Delrin.RTM, Celcon.RTM, Tecaform.TM, different types of sulfons, polyetheramilids and polyetherketones. Other suitable synthetic polymers are the polyamids (nylon), polyester, polysteren, polyacryl, and vinyl polymers, such as polyethylene, 5 polytetrafluorethylene (PTFE), and other analog synthetic materials. Suitable metals for this new support system are biocompatible metals, such as stainless steel, titanium, cobalt alloys, such as Elgiloy.RTM, Nitinol, which is a nickel titanium alloy. Also materials such as ceramics can be used, such as pyrolytic carbon, carbides/silicon nitrides, metal carbides/nitrides, graphite, zircons and aluminum. Also, 10 absorbable polymers, such as dextrane, zelatine, polyglycols, D,L-polylactic acid, D lactic acid and glycolic acid. The leaflets can be made either from tissue or from flexible polymers. Biomaterials that can be used for the present invention are solid tissues as well as decellalurized or modified tissues. Suitable tissues are the xenografts (such as the aortic 15 and pulmonary valve of seal, porcine aortic valve, seal's pericardium, bovine, equine and porcine pericardium), homografts (from human to human) or autografts (from the same patient). The tissues can be treated with chemical compounds such as glutaraldehyde, formaldehyde, epoxids, diimines, aldehydes, anticalcification agents. Suitable polymers for making the leaflets are for example the synthetic polymers, as well as biological 20 polymers or combination of both. Synthetic polymers are for example the polyamids, polyesters, polyacryls, vinyl polymers and the polyacetals (i.e. Delrin.RTM). The new support system for bioprosthetic valves with heart shape commissural posts of the present invention can be covered externally with polytetrafluoroethylene (PTFE) or cloth, tissue, or any other material so to minimize the deterioration of the 25 leaflets and the formation of thrombus. For this reason one of the preferred embodiments of the present invention, is that the support system at the commissural posts may has small openings, to facilitate the positioning and stitching of the PTFE, cloth, tissue or any other suitable material. Also this new support system may have a sewing ring at the external surface to facilitate the surgical implantation of the bioprosthetic valve in 30 humans. The material of the sewing ring that allows the passage of surgical stitches through it can be of silicon, cloth, polyester and other suitable materials. 8 WO 2011/058385 PCT/GR2010/000050 The present support system of bioprosthetic valves with heart shape commissural posts offers an advantage over the commonly used support systems, and this is the large heart shaped openings at the commissural posts. These large openings allows the slight movement of the material or the leaflets made from biocompatible materials, inwards and 5 outwards, during the cardiac cycle. The outwards movement during systole facilitates the opening of the leaflets, while the inwards movement during diastole, allows the better closure of the leaflets, avoiding the regurgitation of the blood. The large heart shape openings at the commissural posts, allows the evenly distribution of forces applied on the leaflets during the cardiac cycle, which forces are responsible for the deterioration of the 10 bioprosthetic valves. This novel support system of the present invention, facilitates the surgical implantation of the bioprosthetic valves, due to the fact that the support system maintain the normal geometry of the human valve, because of the rather hard material, and facilitates the surgical implantation with a continuous stitch or interrupted stitches, 15 surgical techniques widely used ("Tissue Heart Valves", ed. By M.I. Ionescu, publisher Butterorth Inc., Boston, Massachusetts, U.S.A., 1979, pp. 32-34, 107-109, 177). 9

Claims (21)

1. A support system for bioprosthetic cardiac valves constructed of a material comprising an inflow opening defined by an inferior surface of the support system, an outflow opening defined by a superior surface of the support system, three commissural posts, each post 5 having a single heart shaped opening, and intercommissural conjunctions with two horizontal openings with oval closures positioned at a level above said inferior surface, wherein each single heart shaped opening is of a size such that it extends from below said superior surface toward said inferior surface to a level equal to or greater than said horizontal openings, and wherein each single horizontal opening has substantially parallel sides, such that the D intercommissural conjunctions have less open area than closed area.
2. The support system of claim 1, where the material of construction is polyacetal.
3. The support system of claim 1, where the material of construction is a polymer.
4. The support system of claim 1, where the material of construction is a metal or metal alloy.
5 5. The support system of any one of claims 1-4, where said system can be covered totally with polytetrafluoroethylene (PTFE).
6. The support system of any one of claims 1-4, where said system can be covered totally with cloth.
7. The support system of any one of claims 1-4, where said system can be covered 0 totally with tissue.
8. The support system of any one of claims 1-7, where a sewing ring is placed perimetrical.
9. The support system of claim 8, where the sewing ring consists of a polymer.
10. The support system of claim 8, where the sewing ring consists of cloth. 5
11. The support system of claim 8, where the sewing ring consists of silicon.
12. A prosthetic valve, comprising the support system of claim 1 and flexible leaflets. 10
13. The prosthetic valve of claim 12, where the flexible leaflets consist of tissue.
14. The prosthetic valve of claim 12, where the flexible leaflets consist of suitable treated tissue.
15. A prosthetic valve of claim 12, where the flexible leaflets consist of a polymer. 5
16. A support system for bioprosthetic cardiac valves comprising an inflow opening defined by an inferior surface of the support system, an outflow opening defined by a superior surface of the support system, three commissural posts, each post having a single tear drop shaped opening, and intercommissural conjunctions with horizontal openings with oval closures positioned at a level above said inferior surface, wherein each single tear drop shaped opening D is of a size such that it extends from below said superior surface toward said inferior surface to a level equal to said horizontal openings, and wherein each single horizontal opening has substantially parallel sides, wherein there is less open area in the intercommissural conjunctions than closed area.
17. The support system of claim 16, wherein each conjunction comprises two horizontal 5 openings.
18. The support system of claim 16 or claim 17, further comprising a plurality of small holes for stitching surrounding the tear drop shaped opening of each post.
19. The support system of any one of claims 1-15, wherein each single heart shaped opening is of a size such that it extends from below said superior surface toward said inferior 0 surface to a level greater than said horizontal openings.
20. The support system of any one of claims 16-18, wherein the bottom of each single tear drop shaped opening that it extends to a level equal to said horizontal openings has two equal angles of 65 degrees.
21. A support system according to claim 1 or claim 16; or a prosthetic valve according to 5 claim 12, substantially as herein described with reference to any one or more of the examples and/or figures. 11
AU2010317679A 2009-11-11 2010-11-09 Support system for bioprosthetic valves with commisural posts with heart-shaped openings Ceased AU2010317679B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GR20090100617A GR1007028B (en) 2009-11-11 2009-11-11 SUPPORT OF BIO-ADDITIONAL VALVES WITH DIAGNOSTIC HEART SHAPE
GR20090100617 2009-11-11
PCT/GR2010/000050 WO2011058385A1 (en) 2009-11-11 2010-11-09 Support system for bioprosthetic valves with commisural posts with heart-shaped openings

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AU2010317679B2 true AU2010317679B2 (en) 2014-03-27

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DE (1) DE212010000177U1 (en)
GB (1) GB2487034A (en)
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WO (1) WO2011058385A1 (en)

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US20120232646A1 (en) 2012-09-13
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US8585757B2 (en) 2013-11-19
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